In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.
Rights, Regulation, and the Technological Revolution confronts a central question facing modern government: how can regulators respond to both the challenges and opportunities presented by a technologically driven society without sacrificing legitimacy for effectiveness, or weakening the essential conditions of a stable, aspirant moral community? The book analyses developments across biotechnology, information and communications technology, nanotechnology, and neurotechnology. In part one, Regulatory Challenge, it explores the difficulties facing the public control of rapid technological change, focusing on the problems of regulatory effectiveness, connection, legitimacy, and compliance. In part two, Regulatory Opportunity, it covers genetic databases, code and control and the corrosion of moral community. The book argues that as regulators struggle to find adequate frameworks to limit, license, and support new technologies, they will increasingly rely on a technological approach to complement, enhance, and even replace traditional legal strategies. The book breaks new ground by offering the first overarching commentary on the relationship between regulators, industry, and wider society as the new technologies of the 21st century achieve an ever-greater penetration in our daily lives.
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There are limited data on the impact of feedback of incidental Background findings (IFs) from research imaging. We evaluated the impact of UK Biobank's protocol for handling potentially serious IFs in a multi-modal imaging study of 100,000 participants (radiographer 'flagging' with radiologist confirmation of potentially serious IFs) compared with systematic radiologist review of all images.: Brain, cardiac and body magnetic resonance, and dual-energy x-ray Methods absorptiometry scans from the first 1000 imaged UK Biobank participants were independently assessed for potentially serious IFs using both protocols. We surveyed participants with potentially serious IFs and their GPs up to six months after imaging to determine subsequent clinical assessments, final diagnoses, emotional, financial and work or activity impacts.: : Compared with systematic radiologist review, radiographer Conclusions flagging missed some serious diagnoses, but avoided adverse impacts for many participants with non-serious diagnoses. While systematic radiologist review may benefit some participants, UK Biobank's responsibility to avoid both unnecessary harm to larger numbers of participants and burdening of publicly-funded health services suggests that radiographer flagging is a justifiable approach in the UK Biobank imaging study. The potential scale of non-serious final diagnoses raises questions relating to handling IFs in other settings, such as commercial and public health screening.
The authors provide an ethical framework for considering researchers' obligations to human research participants in low-income countries.
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